GMP Internal Auditor Training Kit is designed to increase the understanding of auditing techniques and help participants to accurately interpret and audit against the GMP requirements for good manufacturing process control. Significant attention is given to developing and using a “Audit Methodology” as required by the standard and “FDA GMP Compliance”.

This good training kit provides the process for ensuring all employees receive adequate, relevant, and documented GMP auditor training to enable them to perform their assigned functions in compliance with applicable guidelines/regulations. This training kit outlines practical training approaches to evaluate, establish and/or provide training for FDA regulated industries.

One of the most daunting tasks performed by quality professionals is the prioritization of activities relating to “quality” or “FDA GMP Compliance”. Not only are there internal requirements from the various departments, there exists external demands from various customers and regulatory agencies. Everyone wants everything now and they all want it done correctly!

This training kit is aimed at Quality Assurance auditors and production management for Level 2 internal audits and supplier auditing. To be a business benefit rather than a drain on resources, your auditing programs must be integral to continuous improvement. The key to effective internal auditing and auditing of suppliers is the training of both auditors and auditees in the purpose and relevant techniques of the audit and how these techniques can be channeled to achieve business and compliance improvements.

Participants will learn about the key techniques and thought processes which may be used by auditors to maximize the benefits of each type of audit. These include planning and preparation, the audit team, structuring the audit, close out, CAPAs and follow up.

Through training exercises and case studies, participants will gain the knowledge and skills to plan and conduct effective internal quality audits, report audit findings clearly and undertake effective follow-up audit on corrective actions taken so as to ensure continual improvement.